MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL RESECTION TEMPLATE, LEFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	HUMERAL RESECTION TEMPLATE, LEFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/06/2025, it was reported by a sales representative via (b)(4) that an ar-9200-01l humeral resection template screw broke inside the device.This was discovered during the case with no patient harm.Additional information was received by the rep on 11/13/25.This was discovered during an rsta.All fragments were retrieved and no power was used.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.-visual inspection of the humeral resection template, left noted that the clocking pin was broken off.-functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to wear and tear due to repeated use of the device in the field.

• Brand Name: HUMERAL RESECTION TEMPLATE, LEFT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23657870
• Report Number: 1220246-2025-05217
• Device Sequence Number: 17349589
• Product Code: MDM
• UDI-Device Identifier: 00888867136823
• UDI-Public: (01)00888867136823(11)180102(10)011751
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HUMERAL RESECTION TEMPLATE, LEFT
• Device Catalogue Number: AR-9200-01L
• Device Lot Number: 011751
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown